Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000106538
Ethics application status
Approved
Date submitted
11/12/2014
Date registered
5/02/2015
Date last updated
5/02/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy and safety of artemisinin-based combination therapy: artesunate-amodiaquine (ASAQ) and artemether-lumefantrine (AL) in the treatment of uncomplicated falciparum malaria in 4 provinces of Burundi
Scientific title
Efficacy and safety of artemisinin-based combination therapy: artesunate-amodiaquine (ASAQ) and artemether-lumefantrine (AL) in the treatment of uncomplicated falciparum malaria in 4 provinces of Burundi
Secondary ID [1] 285828 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uncomplicated falciparum malaria 293744 0
Condition category
Condition code
Infection 294044 294044 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients with confirmed falciparum malaria from 4 provinces of Burundi (Bujumbura, Makamba, Karuzi and Gitega) will be treated with artesunate (4mg/kg)-amodiaquine (10 mg/kg) once daily for three days and will be followed for up to 28 days with fixed scheduled clinical and parasitological assessements. Three formulations of fixed combination tablets of artesunate-amodiaquine will be used: 25/67.5 mg; 50/135mg and 100/270 mg). Number of tablet(s) to be adminsitered is based on body weight according to the national policy. Once the target number of patients have been enrolled, a second cohort will be treated with artemether (4 mg/kg)-lumefantrine 25 mg/kg) given in two daily doses for three days and will be followed for up to 28 days with fixed scheduled clinical and parasitological assessements. Fixed combination tablet containing 20 mg artemether and 120 mg lumefantrine will be used: the number of tablets to be administered for the morning and evening dose is based on body weight according to the national policy. All doses for both treatments will be administered under supervsion of medical staff.
Intervention code [1] 290807 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293822 0
proportion of patients with PCR-corrected adequate clinical and parasitological response according to WHO criteria
Timepoint [1] 293822 0
Day 28
Secondary outcome [1] 311941 0
Incidence of adverse events. Known or possible adverse events associated with ASAQ include anorexia, abdominal pain, nausea, fatique, drowziness, dizziness, insomnia and cough. Known or possible adverse events associated to AL include fever, cough, vomiting, anorexia and headache
Timepoint [1] 311941 0
Day 28

Eligibility
Key inclusion criteria
children aged 6 months to 10 years
monoinfection with P falciparum confirmed by microscopy
parasitemia between 1000-200000 parasites (asexual) per microliter
fever (equal or greater than 37.5 celsius) or history of fever within past 24 hours
able to swallow oral medication
ability and willingness to follow protocol procedures and schedule of assessments
written informed consent from parent or guardian
Minimum age
6 Months
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
presence of danger and signs of severe malaria
mixed infection or infection of than P. falciparum detected by microscopy
severely malnourished
fever due to other diseases (measles, acute lower respiratory tract infection, severa diarrhea); chronic or severe hepatic, renal or cardiac diseases; HIV/AIDS
clinical signs of acute jaundice
abnormal level of granulocytes or liver transaminases
regular medication that could interfere with antimalarial pharmacokinetics;
history of hypersensitivity reactions or contraindications to any medicines being used

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/02/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
528
Accrual to date
Final
Recruitment outside Australia
Country [1] 6545 0
Burundi
State/province [1] 6545 0
Karuzi, Makamba, Bujumbura Mairie and Gitega

Funding & Sponsors
Funding source category [1] 290400 0
Government body
Name [1] 290400 0
Ministry of Health
Country [1] 290400 0
Burundi
Primary sponsor type
Government body
Name
Ministry of Public Health
Address
Avenue de l'Hopital No 5
Bujumbura
Country
Burundi
Secondary sponsor category [1] 289118 0
Other Collaborative groups
Name [1] 289118 0
World Health Organisation
Address [1] 289118 0
20 avenue Appia
1211 Geneva 11
Country [1] 289118 0
Switzerland
Secondary sponsor category [2] 289119 0
Charities/Societies/Foundations
Name [2] 289119 0
The Global Funds to Fight AIDS,TB and MALARIA
Address [2] 289119 0
Chemin de Blandonnet 8
1214 Vernier
Country [2] 289119 0
Switzerland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292093 0
Ethics Research Committee, World Health Organisation
Ethics committee address [1] 292093 0
20 avenue Appia
1211 Geneva 11
Ethics committee country [1] 292093 0
Switzerland
Date submitted for ethics approval [1] 292093 0
Approval date [1] 292093 0
17/11/2014
Ethics approval number [1] 292093 0
RPC623

Summary
Brief summary
This is an observational study to monitor the efficacy and safety of artesunate-amodiaquine and artemether-lumefantrine in the treatment of uncomplicated falciparum malaria in children recruited from 4 provinces of Burundi. The protocol follows the standard WHO methods for surveillance of antimalrial drug efficacy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53454 0
Prof Dr NDAYIKUNDA Claudette
Address 53454 0
Centre Hospitalier Universitaire de Kamenge
Boulevard du 28 novembre
Bujumbura
Country 53454 0
Burundi
Phone 53454 0
+257 77721631
Fax 53454 0
Email 53454 0
ndaclau@yahoo.fr
Contact person for public queries
Name 53455 0
Prof Dr NDAYIKUNDA Claudette
Address 53455 0
Centre Hospitalier Universitaire de Kamenge
Boulevard du 28 novembre
Bujumbura
Country 53455 0
Burundi
Phone 53455 0
+257 77721631
Fax 53455 0
Email 53455 0
ndaclau@yahoo.fr
Contact person for scientific queries
Name 53456 0
Prof Dr NDAYIKUNDA Claudette
Address 53456 0
Centre Hospitalier Universitaire de Kamenge
Boulevard du 28 novembre
Bujumbura
Country 53456 0
Burundi
Phone 53456 0
+257 77721631
Fax 53456 0
Email 53456 0
ndaclau@yahoo.fr

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.